BACKGROUND: Asthma management focuses on achieving and maintaining asthma control. Few studies have assessed whether complete and sustained asthma control is maintained in clinical practice after stepping-across ICS/LABA fixed combinations. Aim of this double-blind, double-dummy, randomized, parallel group, controlled study was to demonstrate clinical equivalence between equipotent doses of extrafine beclometasone/formoterol (BDP/F) pMDI and fluticasone/salmeterol (FP/S) Diskus® in maintaining lung function and asthma control. METHODS: A total of 416 asthmatic patients already controlled with FP/S 500/100 μg/day (Diskus®, pMDI or separate inhalers) were randomized to a 12-week treatment with extrafine BDP/F 400/24 μg/day pMDI or FP/S 500/100 μg/day Diskus®. Pre-dose 1-s forced expiratory volume (FEV(1)) was the primary efficacy variable; secondary variables included asthma control questionnaire (ACQ-7) and FEV(1)0-1 h area under the curve (FEV(1)AUC(0-1h)). Safety was assessed through adverse events monitoring and vital signs. RESULTS: After 12 weeks of treatment, pre-dose FEV(1) did not differ between treatments (difference between means 0.01 L; 95% CI -0.03-0.06 L) with no significant changes from baseline in both groups (p = 0.726 and p = 0.783 in BDF/F arm and FP/S, respectively). ACQ-7 score showed that control was maintained after stepping-across to extrafine BDP/F. FEV(1)AUC(0-1h) was significantly higher in BDP/F arm at the beginning (p = 0.004) and at the end of the 12-week treatment period (p = 0.019). No safety issues were reported in both groups. CONCLUSIONS: Patients previously controlled with FP/S in any device formulation can effectively step-across to extrafine BDP/F pMDI, maintaining lung function and asthma control with a 5-min onset of action.
RCT Entities:
BACKGROUND:Asthma management focuses on achieving and maintaining asthma control. Few studies have assessed whether complete and sustained asthma control is maintained in clinical practice after stepping-across ICS/LABA fixed combinations. Aim of this double-blind, double-dummy, randomized, parallel group, controlled study was to demonstrate clinical equivalence between equipotent doses of extrafine beclometasone/formoterol (BDP/F) pMDI and fluticasone/salmeterol (FP/S) Diskus® in maintaining lung function and asthma control. METHODS: A total of 416 asthmatic patients already controlled with FP/S 500/100 μg/day (Diskus®, pMDI or separate inhalers) were randomized to a 12-week treatment with extrafine BDP/F 400/24 μg/day pMDI or FP/S 500/100 μg/day Diskus®. Pre-dose 1-s forced expiratory volume (FEV(1)) was the primary efficacy variable; secondary variables included asthma control questionnaire (ACQ-7) and FEV(1)0-1 h area under the curve (FEV(1)AUC(0-1h)). Safety was assessed through adverse events monitoring and vital signs. RESULTS: After 12 weeks of treatment, pre-dose FEV(1) did not differ between treatments (difference between means 0.01 L; 95% CI -0.03-0.06 L) with no significant changes from baseline in both groups (p = 0.726 and p = 0.783 in BDF/F arm and FP/S, respectively). ACQ-7 score showed that control was maintained after stepping-across to extrafine BDP/F. FEV(1)AUC(0-1h) was significantly higher in BDP/F arm at the beginning (p = 0.004) and at the end of the 12-week treatment period (p = 0.019). No safety issues were reported in both groups. CONCLUSIONS:Patients previously controlled with FP/S in any device formulation can effectively step-across to extrafine BDP/F pMDI, maintaining lung function and asthma control with a 5-min onset of action.
Authors: F Braido; N Scichilone; F Lavorini; O S Usmani; L Dubuske; L P Boulet; R Mosges; C Nunes; M Sanchez-Borges; I J Ansotegui; M Ebisawa; F Levi-Schaffer; L J Rosenwasser; J Bousquet; T Zuberbier; G Walter Canonica; A Cruz; A Yanez; A Yorgancioglu; D Deleanu; G Rodrigo; J Berstein; K Ohta; P Vichyanond; R Pawankar; S N Gonzalez-Diaz; S Nakajima; T Slavyanskaya; A Fink-Wagner; C Baez Loyola; D Ryan; G Passalacqua; J Celedon; J C Ivancevich; K Dobashi; M Zernotti; M Akdis; S Benjaponpitak; S Bonini; W Burks; L Caraballo; Z Awad El-Sayed; S Fineman; P Greenberger; E Hossny; J A Ortega-Martell; H Saito; M Tang; L Zhang Journal: World Allergy Organ J Date: 2016-10-28 Impact factor: 4.084
Authors: F Braido; N Scichilone; F Lavorini; O S Usmani; L Dubuske; L P Boulet; R Mosges; C Nunes; M Sánchez-Borges; I J Ansotegui; M Ebisawa; F Levi-Schaffer; L J Rosenwasser; J Bousquet; T Zuberbier; G Walter Canonica Journal: Asthma Res Pract Date: 2016-10-28